MAUDE Adverse Event Report: HAEMONETICS CORPORATION TEG® HEMOSTASIS ANALYZER SYSTEM; TEG 6S US UNIT PACK

Model Number	TEG 6S UNIT PACK
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/27/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Results were achieved after 4 cartridges were used.Customer indicated to haemonetics that delay in processing was not responsible for patient death.A field service engineer was dispatched and inspected the teg6s and checked the calibration settings of the unit and found no issues.Ran qc levels 1 and 2.Unit meets manufacturer specifications.
Event or Problem Description
On (b)(6) 2020, customer informed haemonetics of a patient fatality that happened at (b)(6) medical center in (b)(6).Palette mapping, on a teg6s, gave a sudlite error in the middle of testing and there was a delay in obtaining the results.

• Brand Name: TEG® HEMOSTASIS ANALYZER SYSTEM
• Common Device Name: TEG 6S US UNIT PACK
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 9733033
• Report Number: 1219343-2020-00012
• Device Sequence Number: 366854
• Product Code: JOZ
• UDI-Device Identifier: 30812747018351
• UDI-Public: (01)30812747018351
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D238254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TEG 6S UNIT PACK
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death